ADASUVE® (loxapine) inhalation powder, for oral inhalation use, can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on site to supplies and personnel trained to manage acute bronchospasm, and ready access to emergency response services…
Read More Important Safety
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Galen wants you to have access to resources and support that may provide additional information. The links below will direct you to third-party websites that you may find helpful.

American Association for Emergency Psychiatry (AAEP)

AAEP promotes timely, compassionate, and effective mental health services for persons
with mental illnesses, regardless of their ability to pay, in all crisis and emergency
care settings.

American College of Emergency Physicians (ACEP)

ACEP promotes the highest quality of emergency care and is the leading advocate
for emergency physicians, their patients, and the public.

American Nurses Association (ANA)

ANA is the only full-service professional organization representing the interests
of the nation’s 3.1 million registered nurses through its constituent and state
nurses associations and its organizational affiliates. The ANA advances the nursing
profession by fostering high standards of nursing practice, promoting the rights
of nurses in the workplace, projecting a positive and realistic view of nursing,
and by lobbying the Congress and regulatory agencies on health care issues affecting
nurses and the public.

American Psychiatric Association (APA)

APA, founded in 1844, is the world’s largest psychiatric organization. It is a medical
specialty society representing more than 33,000 psychiatric physicians from the
United States and around the world.

American Psychiatric Nurses Association (APNA)

APNA champions psychiatric-mental health nursing and advocates for mental health
care through the development of positions on key issues, the widespread dissemination
of current knowledge, and developments in psychiatric mental health nursing, and
through collaboration with consumer groups to promote evidence-based advances in
recovery-focused assessment, diagnosis, treatment, and evaluation of persons with
mental illness and substance use disorders.

American Psychiatric Foundation (APF)

The mission of the APF is “advancing mental health, overcoming mental illness, and
eliminating stigma.” To accomplish this mission, the APF promotes awareness of mental
illnesses and the effectiveness of treatment, the importance of early intervention,
access to care, and the need for high quality services and treatment through a combination
of public and professional education, research, research training, grants, and awards.

American Society of Health-System Pharmacists (ASHP)

ASHP is the national professional organization whose nearly 40,000 members include
pharmacists, pharmacy technicians, and pharmacy students who provide patient care
services in hospitals, health systems, and ambulatory clinics. For 70 years, the
Society has been on the forefront of efforts to improve medication use and enhance
patient safety.

College of Psychiatric and Neurologic Pharmacists (CPNP)

The CPNP promotes excellence in pharmacy practice, education, and research to optimize
treatment outcomes of individuals affected by psychiatric and neurologic disorders.

Emergency Medical Associates (EMA)

EMA is a group of professional physician partners uniquely supported by exceptional
solutions for the measurable success of their hospital partners. The organization
is focused on the provision of clinical excellence and nationally recognized emergency
services to hospitals and health systems.

Emergency Nurses Association (ENA)

Originally aimed at teaching and networking, the ENA has evolved into an authority,
advocate, lobbyist, and voice for emergency nursing. ENA has over 40,000 members
and continues to grow, with members representing over 35 countries around the world.
The mission of the ENA is to advocate for patient safety and excellence in emergency
nursing practice.

Institute on Psychiatric Services (IPS)

IPS is the American Psychiatric Association’s leading educational conference on
public, community, and clinical psychiatry.

Psych Congress Network

Psych Congress Network keeps mental health professionals current on the latest clinical
news, research breakthroughs, and peer perspectives. The goal of Psych Congress
Network is to serve as the go-to resource for clinicians seeking the highest quality
of care for their patients.

Society for Academic Emergency Medicine (SAEM)

SAEM is dedicated to improving care of the acutely ill and injured patient by improving
research and education. To achieve this mission, SAEM influences health policy through
forums, publications, inter-organizational collaboration, policy development, and
consultation services for physicians, teachers, researchers, and students.

Society of Emergency Medicine Physician Assistants (SEMPA)

SEMPA is the exclusive professional organization representing physician assistants
in emergency medicine. SEMPA works to continually support the professional, clinical,
and personal development of emergency medicine physician assistants. The organization
also works to educate the public about the role, importance, and value of physician
assistants in the emergency department.

Society of Hospital Medicine (SHM)

SHM is the largest organization in the nation representing hospitalists and the
practice of hospital medicine.

PATIENT RESOURCES

Depression and Bipolar Support Alliance (DBSA)

DBSA is an organization dedicated to providing education on mood disorders to patients,
physicians, and the public.

Mental Health America (MHA)

MHA, the leading advocacy organization addressing the full spectrum of mental and
substance use conditions and their effects nationwide, works to inform, advocate,
and enable access to quality behavioral health services for all Americans.

National Alliance on Mental Illness (NAMI)

NAMI is an organization that provides resources for treatments options, services,
support groups, and research for patients with mental illness.

National Council for Behavioral Health (NCBH)

NCBH is the unifying voice of America’s community mental health organizations.

Schizophrenia and Related Disorders Alliance of America (SARDAA)

SARDAA promotes improvement in the lives of people with schizophrenia-related illnesses
and their families by providing support, hope, and awareness so that early diagnosis,
treatment, and community services increase recovery.

INDICATIONS AND USAGE

ADASUVE® (loxapine) inhalation powder, for oral inhalation use, is
a typical antipsychotic indicated for the acute treatment of agitation associated
with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in
2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.

Limitations of Use: As part of the ADASUVE Risk Evaluation
and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE
must be administered only in an enrolled healthcare facility.

IMPORTANT SAFETY INFORMATION

ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on site to supplies and personnel trained to manage acute bronchospasm, and ready access to emergency response services. Facilities must have a short-acting bronchodilator (eg, albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.

Because of the risk of bronchospasm, ADASUVE is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE
REMS.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs
are at an increased risk of death. ADASUVE is not approved for the treatment of
patients with dementia-related psychosis.

ADASUVE is contraindicated in patients with the following:

Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD),
or other lung disease associated with bronchospasm

Acute respiratory signs/symptoms (eg, wheezing)

Current use of medications to treat airways disease, such as asthma or COPD

History of bronchospasm following ADASUVE treatment

Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred
with oral loxapine and amoxapine

ADASUVE must be administered only by a healthcare professional

Prior to administration, all patients must be screened for a history of pulmonary
disease and examined (including chest auscultation) for respiratory abnormalities
(eg, wheezing)

Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation
using the single-use inhaler

After ADASUVE administration, patients must be monitored for signs and symptoms
of bronchospasm at least every 15 minutes for at least 1 hour

ADASUVE can cause sedation, which can mask the symptoms of bronchospasm

ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution
in patients with known cardiovascular disease, cerebrovascular disease, or conditions
that would predispose patients to hypotension. In the presence of severe hypotension
requiring vasopressor therapy, epinephrine should not be used

ADASUVE may increase the risk of falls, which could cause fractures or other injuries.
Patients taking antipsychotics with certain health conditions or those on long-term therapy
should be evaluated by their healthcare professional for the potential risk of falls

Use ADASUVE with caution in patients with a history of seizures or with conditions
that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures
have occurred in patients treated with oral loxapine, and can also occur in epileptic
patients

Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking,
and motor skills

The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants

Treatment with antipsychotic drugs caused an increased incidence of stroke and transient
ischemic attack in elderly patients with dementia-related psychosis; ADASUVE is
not approved for the treatment of patients with dementia-related psychosis

Use of ADASUVE may exacerbate glaucoma or cause urinary retention

The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical
studies in patients with agitation treated with ADASUVE were dysgeusia, sedation,
and throat irritation

Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester
of pregnancy are at risk of extrapyramidal and/or
withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus

Nursing mothers: Discontinue drug or nursing, taking into account the importance
of the drug to the mother

The safety and effectiveness of ADASUVE in pediatric patients have not been established

INDICATIONS AND USAGE

ADASUVE® (loxapine) inhalation powder, for oral inhalation use, is
a typical antipsychotic indicated for the acute treatment of agitation associated
with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in
2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.

Limitations of Use: As part of the ADASUVE Risk Evaluation
and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE
must be administered only in an enrolled healthcare facility.

IMPORTANT SAFETY INFORMATION

ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on site to supplies and personnel trained to manage acute bronchospasm, and ready access to emergency response services. Facilities must have a short-acting bronchodilator (eg, albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.

Because of the risk of bronchospasm, ADASUVE is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE
REMS.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs
are at an increased risk of death. ADASUVE is not approved for the treatment of
patients with dementia-related psychosis.

ADASUVE is contraindicated in patients with the following:

Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD),
or other lung disease associated with bronchospasm

Acute respiratory signs/symptoms (eg, wheezing)

Current use of medications to treat airways disease, such as asthma or COPD

History of bronchospasm following ADASUVE treatment

Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred
with oral loxapine and amoxapine

ADASUVE must be administered only by a healthcare professional

Prior to administration, all patients must be screened for a history of pulmonary
disease and examined (including chest auscultation) for respiratory abnormalities
(eg, wheezing)

Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation
using the single-use inhaler

After ADASUVE administration, patients must be monitored for signs and symptoms
of bronchospasm at least every 15 minutes for at least 1 hour

ADASUVE can cause sedation, which can mask the symptoms of bronchospasm

ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution
in patients with known cardiovascular disease, cerebrovascular disease, or conditions
that would predispose patients to hypotension. In the presence of severe hypotension
requiring vasopressor therapy, epinephrine should not be used

ADASUVE may increase the risk of falls, which could cause fractures or other injuries.
Patients taking antipsychotics with certain health conditions or those on long-term therapy
should be evaluated by their healthcare professional for the potential risk of falls

Use ADASUVE with caution in patients with a history of seizures or with conditions
that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures
have occurred in patients treated with oral loxapine, and can also occur in epileptic
patients

Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking,
and motor skills

The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants

Treatment with antipsychotic drugs caused an increased incidence of stroke and transient
ischemic attack in elderly patients with dementia-related psychosis; ADASUVE is
not approved for the treatment of patients with dementia-related psychosis

Use of ADASUVE may exacerbate glaucoma or cause urinary retention

The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical
studies in patients with agitation treated with ADASUVE were dysgeusia, sedation,
and throat irritation

Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester
of pregnancy are at risk of extrapyramidal and/or
withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus

Nursing mothers: Discontinue drug or nursing, taking into account the importance
of the drug to the mother

The safety and effectiveness of ADASUVE in pediatric patients have not been established

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ADASUVE REMS PROGRAM

To administer ADASUVE® (loxapine)
inhalation powder, healthcare facilities
must enroll in the ADASUVE REMS Program

Because of the risk of bronchospasm, ADASUVE can only be administered in healthcare facilities that are enrolled in the ADASUVE
REMS Program.

For more information on the ADASUVE REMS Program,
please call 855-755-0492 or visit

By clicking the above link, you will leave ADASUVE.COM and be redirected to the
ADASUVE REMS Program site.